If anyone thinks of specialty pharmacies, the first thing that comes to mind is the pharmacy in Massachusetts which had the deadly meningitis outbreak that killed 50 people based on tainted steroid shots. The issue at hand was the contamination of sterile drugs which were improperly handled. From first hand experience, I know that specialty pharmacies have an important role. Most medications they compound (make) have a short life span and require special handling instructions.
What Compounding Pharmacies do?
Compounding pharmacies traditionally alter or mix drugs to meet a patient’s specific need. But in recent decades, some compounders, spurred in part by drug shortages, have begun producing large volumes of some of the highest-risk drugs, often without individual prescriptions. These medications often are shipped across state lines to hospitals and clinics, including veterinary clinics. Most hospitals are not equipped to perform compounding. These pharmacies don’t make drugs like a drug manufacturer would but rather they mix drugs together. They still require sterile conditions to ensure no contamination occurs. They are not dealing with coated tablets from a bottle but rather liquids or powders.
Who Needs Compounding Pharmacies?
Nearly 70 percent of hospitals rely to some degree on specialty pharmacies for critical medications that control pain, induce labor, anesthetize surgical patients and provide intravenous nutrition, according to industry estimates. Compounding is time consuming as well as inventory heavy. If heavy regulation is imposed upon specialty pharmacies, that’s going to increase the workload in the hospital pharmacy. When you have a patient admitted or someone who comes to the emergency room, you can’t say, “Hold on while we make this up for you.” They needed it five minutes ago.
Why the Regulation?
But now states are cracking down on specialty pharmacies by conducting surprise inspections and weighing proposals to require companies to obtain special permits to mix sterile drugs. About a dozen states, including Maryland and Virginia, are considering legislation that would require stricter licensing requirements for specialty pharmacies. Keep in mind, when they screw up, patients get injured or can die. The need is there to regulate and ensure that safety precautions are in place to protect the patient.
Compounding pharmacies are primarily regulated by state authorities, but enforcement is uneven across state lines. They might have one set of standards in Iowa which might be stronger than Wisconsin. They have to ensure all state regulations are met. Compounders are not subject to the Food and Drug Administration’s strict safety standards for drugmakers, nor are their products approved by the agency. Consider them your specialty Walgreens.
Have you received medication from a specialty pharmacy?